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FDA Nod For EPZM, RARE, Court Rules In MYL's Favor, Ocuphire To Hop Onto Nasdaq, ALPN Soars

pharma 051017 19jun20 lt

Today's Daily Dose brings you news about Alpine Immune's deal with AbbVie; FDA approval of Epizyme's TAZVERIK and Ultragenyx Pharma's Crysvita for new indications; reverse merger between privately-held Ocuphire Pharma and Rexahn Pharma and Court ruling in Biogen's Tecfidera patent suit.

Read on…

1. Alpine Soars On AbbVie Deal

Shares of Alpine Immune Sciences Inc. (ALPN) soared as much as 220 percent in intraday trading on Thursday, following an exclusive worldwide option and license agreement with AbbVie Inc. (ABBV) for ALPN-101.

Alpine Immune's ALPN-101 is a phase II-ready, first-in-class dual CD28/ICOS costimulation antagonist for multiple inflammatory disease indications.

Under the license agreement, Alpine has granted AbbVie an option to license worldwide rights to ALPN-101 and in turn stands to receive $60 million in an upfront cash payment and up to $805 million for the exercise of the option and success-based development, regulatory and commercial milestones. In addition, Alpine is entitled to receive tiered royalties on net sales of ALPN-101.

During the option period, Alpine will conduct a phase II study in systemic lupus erythematosus. Upon exercise of the option, AbbVie will be responsible for all future clinical development, manufacturing, and commercialization activities for ALPN-101.

ALPN touched a new high of $15 in intraday trading on Thursday, before closing at $10.95, up 124.85%.

2. FDA Says 'Yes' To Additional Indication of Epizyme's Tazverik

The FDA has granted accelerated approval for Epizyme Inc.'s (EPZM) TAZVERIK in the additional indication of relapsed/refractory follicular lymphoma.

The accelerated approval granted to TAZVERIK on Thursday is for two indications:

-- Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
-- Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.

The drug received its initial accelerated approval in the U.S. in January of this year for the treatment of adults and pediatric patients aged 16 years and older with epithelioid sarcoma.

Continued approval for the indications depends upon the positive outcomes in confirmatory trials.

The net sales of TAZVERIK in the U.S. from the first two months of commercialization following its launch on February 1, 2020, were $1.3 million. TAZVERIK could bring in peak sales of over $1 billion in annual sales, according to the Company.

EPZM closed Thursday's trading at $20.46, up 4.82%. In after-hours, the stock dropped 1.27% and was at $20.20.

3. Selecta, Sarepta Enter Into Research License and Option Deal

Selecta Biosciences Inc. (SELB) has granted Sarepta Therapeutics (SRPT) an option to license the rights to develop and commercialize its immune tolerance platform, ImmTOR, for use in Duchenne muscular dystrophy and certain limb-girdle muscular dystrophies under a research license and option agreement between the two companies.

In advance of exercising its option, Sarepta will conduct research and evaluate the utility of ImmTOR to minimize or prevent the formation of neutralizing antibodies (NAb) to adeno-associated virus (AAV) in connection with the administration of Sarepta's DMD and LGMD gene therapy candidates.

Under the terms of the research license and option agreement, Sarepta will make an initial payment to Selecta, and Selecta is eligible to receive certain pre-clinical milestone fees. If Sarepta exercises its options to enter any commercial license agreements, Selecta will be eligible for additional development, regulatory and commercial milestone payments, as well as tiered royalties on net product sales.

Additional financial details are being kept under wraps.

SELB closed Thursday's trading at $2.70, up 7.36%. In after-hours, the stock gained 3.70% to $2.80.

4. Ocuphire To Hop Onto Nasdaq Via Reverse Merger With Rexahn

Rexahn Pharmaceuticals Inc. (REXN) has entered into a merger agreement with privately-held Ocuphire Pharma Inc., under which Ocuphire will merge with a wholly-owned subsidiary of Rexahn in an all-stock transaction.

The transaction, which is expected to close in the second half of 2020, will create a combined company that will operate in the name of Ocuphire Pharma Inc. and will trade on the Nasdaq Capital Market under the ticker symbol "OCUP." The combined company will focus on the advancement of Ocuphire's late-stage pipeline of ophthalmic drug candidates.

Ocuphire's product candidates include Nyxol Eye Drops, a once-daily eye drop formulation of phentolamine mesylate being developed to treat dim light or night vision disturbances, pharmacologically-induced mydriasis, and presbyopia, and APX3330, a twice-a-day oral tablet, designed to target multiple pathways relevant to retinal diseases, such as diabetic retinopathy and diabetic macular edema.

Certain institutional healthcare and accredited Investors have committed $21.15 million in a private placement that will close immediately prior to the closing of the merger, according to Ocuphire.

REXN closed Thursday's trading at $3.50, up 23.24%.

5. Court Rules In Favor Of Mylan In Tecfidera Patent Suit

The U.S. District Court for the Northern District of West Virginia has invalidated Biogen Inc.'s (BIIB) patent covering its multiple sclerosis Tecfidera, clearing the way for Mylan's launch of a generic version of the drug. The patent could have otherwise delayed generic competition until 2028.

According to data science firm IQVIA, sales of Tecfidera in the U.S. for the 12 months ending April 30, 2020, were approximately $3.78 billion.

Mylan believes it is one of the first companies to have sought approval for a generic version of Tecfidera and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Mylan's ANDA is pending with the FDA.

MYL closed Thursday's trading at $16.33, up 2.25%. BIIB closed the day's trading at $260.30, down 7.52%.

6. Ultragenyx Pharma's Crysvita Gets FDA Approval For Second Indication

Ultragenyx Pharmaceutical Inc.'s (RARE) Crysvita has received FDA approval for the expanded indication of tumor-induced osteomalacia.

Tumor-Induced Osteomalacia, or TIO, caused by hormone fibroblast growth factor 23 (FGF-23), is characterized by typically small benign tumors that are hard to find or impossible to remove. People with TIO have low blood phosphorus, weak muscles, bone pain, and broken bones.

Discovered by Kyowa Kirin, Crysvita was approved by the FDA in April 2018 to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets.

"The FDA approval of Crysvita marks the first treatment option that addresses the cause of the severe hypophosphatemia and osteomalacia resulting from these rare tumors," said Camille L. Bedrosian, Chief Medical Officer of Ultragenyx.

Crysvita brought in annual revenue of $87.3 million for Ultragenyx in 2019, and the drug is expected to record revenue in the range of $125 million to $140 million this year.

RARE closed Thursday's trading at $72.48, up 1.38%.

7. Stocks That Moved On No News

Aethlon Medical Inc. (AEMD) closed Thursday's trading at $2.67, up 89.36%.

IVERIC bio Inc. (ISEE) closed Thursday's trading at $6.13, up 38.06%.

Ovid Therapeutics Inc. (OVID) closed Thursday's trading at $7.37, up 35.73%.

Millendo Therapeutics, Inc. (MLND) closed Thursday's trading at $2.71, down 17.38%.

Pfenex Inc. (PFNX) closed Thursday's trading at $8.15, down 10.34%.

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